阿斯利康(AZN)与第一三共开发Datroway获欧盟批准 有望挖掘欧洲市场商业潜力

金吾财讯
Jul 31

金吾财讯 | 阿斯利康(AZN)对外宣布,欧盟委员会正式批准其与第一三共(DSNKY)联合开发的抗体药物偶联物Datroway新增第二项乳腺癌适应症。此次获批将推动这款静脉输注药物落地27个欧盟成员国,同时可在挪威、冰岛、列支敦士登进行销售,用于特定三阴性乳腺癌患者的一线单药治疗。三阴性乳腺癌在全部乳腺癌病例当中占比约15%,存在尚未被充分满足的临床治疗需求。Datroway此前已经在欧盟获批作为乳腺癌患者的后线治疗方案,面向肿瘤细胞表达部分激素受体(HR阳性)、不存在高水平HER2蛋白(HER2阴性)的人群。本次新适应症划定适用人群范围,针对无法接受PD-1/PD-L1抑制剂治疗、不可切除或者发生转移的TNBC成年患者,进一步拓宽药物的临床使用场景,完善产品在乳腺癌赛道的布局。该项审批落地存在前期铺垫,欧洲药品管理局人用药品委员会已于上月针对Datroway用于三阴性乳腺癌适应症出具积极意见,欧盟委员会参考相关结论完成最终审批。伴随适应症持续扩容,Datroway有望持续挖掘欧洲市场商业潜力,市场后续将持续跟踪该药物后续市场渗透率、全球其他地区审批进展以及同类ADC药物的竞争格局变化。

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